Manager/Associate Director, US Regulatory Affairs

04 Aug, 2022

Jobs

Manager/Associate Director, US Regulatory Affairs

Zoetis
Kalamazoo, MI

Job Scope:

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops manufactures and markets veterinary vaccines and medicines complemented by diagnostic products, genetic tests, biodevices, and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries.

 

The VMRA-US Biopharma Manager has been created to address the growing need for biopharmaceutical regulatory support in the region and as part of global development programs. This coincides with the expanding biopharmaceutical portfolio currently under development within Zoetis. Expertise and support are needed for all phases of product development and in-line support, including manufacturing, safety, and efficacy considerations. The position will primarily involve products under FDA-CVM jurisdiction but there is opportunity for it to also include products under USDA-CVB jurisdiction. The position will require a highly motivated, independent individual who can effectively collaborate with other team members and with US Regulatory Authorities to advance projects.

 

There is a possibility for this role to be remote.

 

Responsibilities of the job:

 

The successful candidate will provide regulatory guidance and technical support for the US and, where appropriate, global veterinary biopharmaceutical development project teams. The person will be responsible for ensuring that these products are developed, approved, and maintained in full compliance with FDA-CVM (or USDA-CVB) requirements. To accomplish these responsibilities, the candidate will liaise closely with regulatory, laboratory science, and clinical team members to facilitate product development, approval and maintenance consistent with the company operating plans and the biopharmaceutical project portfolio. The candidate will also liaise with EU and CALAR regulatory colleagues to support global registration activities, where appropriate. As needed, the candidate will also interaction with Global Therapeutic Research, Global Biologics Research, Global Commercial Development (GCD), Global Manufacturing, Project Management, and other partner groups to drive regulatory aspects of project activities consistent with Company objectives.

 

Key responsibilities follow:

Serve as regulatory subject matter expert and member on multidisciplinary project teams responsible for developing veterinary biopharmaceutical products. Help develop and implement the regulatory strategy for assigned teams, accepting the responsibility of all US regulatory submissions and interactions for that project. Serve as liaison with Global Research and other VMRD colleagues to help provide early regulatory input into early phase projects. Liaise with GCD and Therapeutic Area Leads to establish suitable product profiles, regulatory jurisdiction, label claims, and product support materials, as well as assemble and defend stage-gate analyses. Assemble original and supplemental applications and coordinate subsequent responses to US Regulatory Authority questions. Liaise directly with US Regulatory Authorities as needed to achieve objectives. Liaise with EU and CALAR regulatory staff to facilitate global registration activities, where appropriate. Provide regulatory support and guidance regarding Global Manufacturing initiatives and Commercial market enhancements.

 

Minimum Skills, Education, Experience and Attributes:

Bachelor’s or Master’s degree, in a relevant scientific discipline (animal science, veterinary medicine, immunology, toxicology/pharmacology or similar).  DVM and/or PhD are highly desirable. At least 5 years’ experience between US regulatory affairs and a related discipline, involving interaction with the FDA-CVM. Interaction with USDA-CVB and several years of practical experience in an animal science discipline or in the practice of veterinary medicine is highly desirable. Demonstrated abilities in areas of regulatory interpretation and procedures including phased, original, and supplemental applications. Understanding of the veterinary medicinal product development process, including early and late-stage development activities. Knowledge in terms of safety/efficacy and dossier assembly. Knowledge in the production and testing of biopharmaceutical veterinary medicinal products is desirable, especially in terms of CMC requirements.

Excellent oral and written communication and negotiation skills and a demonstrated ability to multi-task and work in a team environment (including virtual). Need to be fluent in English. Good functional knowledge of Microsoft platforms and associated Office suite programs.   Well-developed verbal and written communications skills, and a.

 

 

 

 

Full time

 

 

 

 

Regular

 

 

 

 

Colleague

 

 

 

 

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

 

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

 

 

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

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Job posted: 2022-08-04